Perihilar CholangiocarcinomaRACCOONNCT05546372
Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma
A study testing Endobiliary radiofrequency ablation (eRFA) and uncovered self-expanding metal stent (uSEMS) in people with Perihilar Cholangiocarcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
A multicentre, parallel group, open label, randomized controlled trial comparing endobiliary RFA prior to metal stent placement with stent placement only in patients with inoperable perihilar cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perihilar Cholangiocarcinoma
- What is being tested?
- Endobiliary radiofrequency ablation (eRFA) and uncovered self-expanding metal stent (uSEMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Oct 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older.
- Capable of providing written and oral informed consent.
- Histological or cytological proof of perihilar CCA (adenocarcinoma).
- Perihilar biliary obstruction with an indication for drainage with uSEMS.*
- Advanced (no candidate for surgical resection) due to metastases, vascular or lymph node (N2) involvement on imaging or during staging laparoscopy according to multidisciplinary team (MDT).
- Only patients with pCCA are eligible however in case of reasonable doubt between intrahepatic CCA with a perihilar biliary obstruction or massforming pCCA, patients can be included.
Who cannot join
- Patients who potentially qualify for curative resection of pCCA.
- pCCA eligible for liver transplantation.
- Life-expectancy less than 3 months.
- ERCP and PTC technically not feasible.
- Uncontrolled coagulopathy (PTT >1,5x prolonged or thrombocytes below 40*10E9/L).
- Ongoing cholangitis or liver abscess. Patients are required to be off antibiotic treatment for cholangitis and/or liver abscess at least 7 days.
- Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study.
- Patients who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC location VUmc
Amsterdam, 1081HV
Esmée Smit, MD, e.smit1@amsterdamumc.nl
About this study
Official title: Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial
A multicentre, parallel group, open label, randomized controlled trial comparing endobiliary RFA prior to metal stent placement with stent placement only in patients with inoperable perihilar cholangiocarcinoma.
- Conditions
- Perihilar Cholangiocarcinoma
- Being tested
- Endobiliary radiofrequency ablation (eRFA), uncovered self-expanding metal stent (uSEMS)
- Keywords
- Endobiliary radiofrequency ablation, Stent patency
- Medical subject headings
- Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobiliary radiofrequency ablation (eRFA)Device
Intraductal radiofrequency ablation of tumor prior to stent placement
uncovered self-expanding metal stent (uSEMS)Device
Intraductal placement of uncovered metal stent
| Study group | Role | What they receive |
|---|---|---|
| Endobiliary RFA + stent placement | Experimental | Not described Receives: Device: Endobiliary radiofrequency ablation (eRFA); Device: uncovered self-expanding metal stent (uSEMS) |
| Stent placement only | Active comparator | Not described Receives: Device: uncovered self-expanding metal stent (uSEMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to biliary obstruction
Defined as period between initial procedure and recurrence of biliary obstruction. Recurrence of biliary obstruction is defined as recurrent jaundice (conjugated bilirubin ≥ 40 umol/l (≥2.3 mg/dl)), presence of biochemical evidence of cholestasis along with dilatation of the drained bile duct(s), or endoscopic findings suggesting stent occlusion.
Measured: Through study completion, max 1 year
Secondary outcomes (11)
Quality of life expressed in quality adjusted life-years (QALYs)
EORTC QLQ-C30, BIL21 and EQ-5D questionnaires are to be filled out 4 weeks and every3 months after the intervention
Measured: Through study completion, max 1 year
Number of patients with technical success of initial ablation
Defined as completion of ablation of the malignant stenosis through which the stent will be placed using RFA for 120 seconds with 7W.
Measured: During intervention
Number of patients with functional success
In case of inadequate drainage prior to the procedure (bilirubin ≥40 umol/L [≥2.3 mg/dl]), defined as 50% decrease or normalization of bilirubin level within 14 days of the procedure or relieve of symptoms in case of cholangitis. In case of sufficient drainage prior to the procedure, a persistent bilirubin level <40 umol/L (<2.3 mg/dl) after 14 days is considered functional success.
Measured: 14 days
Presumed reason of recurrent biliary obstruction
- Stent occlusion due to tumour ingrowth
- Stent occlusion due to tumour overgrowth
- Stent occlusion due to sludge with/or without stones, hemobilia, food impaction
- Stent migration
Measured: Through study completion, an average of 1 year
Need for unscheduled re-intervention (PTC and/or ERCP) to achieve adequate biliary drainage.
Measured: Through study completion, an average of 1 year
Need for external drainage catheters.
Measured: Through study completion, an average of 1 year
Time to re-intervention.
Measured: Through study completion, an average of 1 year
Stent patency after repeated eRFA.
Measured: Through study completion, an average of 1 year
Adverse events within 30 days after the procedu
Measured: 30 days
Overall survival.
Measured: Through study completion
Healthcare costs.
Measured: Through study completion, max 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start22 Oct 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perihilar CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, Leiden University Medical Center, UMC Utrecht, University Medical Center Groningen, St. Antonius Hospital, Medisch Spectrum Twente, Maastricht University Medical Center, Clinical Hospital Colentina, Institute for Clinical and Experimental Medicine, Orlando Health, Inc., University Hospital, Ghent, Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Rogier P. Voermans, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546372
- Sponsor's protocol ID
- NL76591.029.22
- Acronym
- RACCOON
- Status last verified
- May 2026
- First submitted
- 25 Aug 2022
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05546372
- Acronym / sponsor ID
- RACCOON / NL76591.029.22
- Conditions
- Perihilar Cholangiocarcinoma
- Keywords
- Endobiliary radiofrequency ablation, Stent patency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Erasmus Medical Center, Leiden University Medical Center, UMC Utrecht, University Medical Center Groningen, St. Antonius Hospital, Medisch Spectrum Twente, Maastricht University Medical Center, Clinical Hospital Colentina, Institute for Clinical and Experimental Medicine, Orlando Health, Inc., University Hospital, Ghent, Universitaire Ziekenhuizen KU Leuven
- Study start
- 22 Oct 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicentre, parallel group, open label, randomized controlled trial comparing endobiliary RFA prior to metal stent placement with stent placement only in patients with inoperable perihilar cholangiocarcinoma.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endobiliary RFA + stent placement | Experimental | Device: Endobiliary radiofrequency ablation (eRFA), Device: uncovered self-expanding metal stent (uSEMS) |
| Stent placement only | Active comparator | Device: uncovered self-expanding metal stent (uSEMS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older.
- Capable of providing written and oral informed consent.
- Histological or cytological proof of perihilar CCA (adenocarcinoma).
- Perihilar biliary obstruction with an indication for drainage with uSEMS.*
- Advanced (no candidate for surgical resection) due to metastases, vascular or lymph node (N2) involvement on imaging or during staging laparoscopy according to multidisciplinary team (MDT).
Key exclusion criteria (8 listed)
- Patients who potentially qualify for curative resection of pCCA.
- pCCA eligible for liver transplantation.
- Life-expectancy less than 3 months.
- ERCP and PTC technically not feasible.
- Uncontrolled coagulopathy (PTT >1,5x prolonged or thrombocytes below 40*10E9/L).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endobiliary radiofrequency ablation (eRFA)Intraductal radiofrequency ablation of tumor prior to stent placement | Device | Endobiliary RFA + stent placement |
| uncovered self-expanding metal stent (uSEMS)Intraductal placement of uncovered metal stent | Device | Endobiliary RFA + stent placement, Stent placement only |
Primary outcome
Time to biliary obstruction
Time frame: Through study completion, max 1 year
Defined as period between initial procedure and recurrence of biliary obstruction. Recurrence of biliary obstruction is defined as recurrent jaundice (conjugated bilirubin ≥ 40 umol/l (≥2.3 mg/dl)), presence of biochemical evidence of cholestasis along with dilatation of the drained bile duct(s), or endoscopic findings suggesting stent occlusion.
11 secondary outcomes
Quality of life expressed in quality adjusted life-years (QALYs)
Time frame: Through study completion, max 1 year
Number of patients with technical success of initial ablation
Time frame: During intervention
Number of patients with functional success
Time frame: 14 days
Presumed reason of recurrent biliary obstruction
Time frame: Through study completion, an average of 1 year
Need for unscheduled re-intervention (PTC and/or ERCP) to achieve adequate biliary drainage.
Time frame: Through study completion, an average of 1 year
Need for external drainage catheters.
Time frame: Through study completion, an average of 1 year
Time to re-intervention.
Time frame: Through study completion, an average of 1 year
Stent patency after repeated eRFA.
Time frame: Through study completion, an average of 1 year
Adverse events within 30 days after the procedu
Time frame: 30 days
Overall survival.
Time frame: Through study completion
Healthcare costs.
Time frame: Through study completion, max 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endobiliary radiofrequency ablation (eRFA) and uncovered self-expanding metal stent (uSEMS) in people with Perihilar Cholangiocarcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esmée Smit (+31204440613, e.smit1@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to biliary obstruction (time frame: Through study completion, max 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.